Clinical Trial 43618

Coral Gables, FL 33134


Summary:

A study is now evaluating the safety and effectiveness of an investigational medication to treat hidradenitis suppurativa. HS is a chronic skin condition featuring lumps in places such as the armpits or groin.The skin lesions develop as a result of inflammation and infection of sweat glands. This condition features pea- to marble-sized lumps under the skin that can be painful and tend to enlarge and drain pus. They usually occur where skin rubs together, such as in the armpits, groin, and buttocks. Medications, corticosteroid injections, and sometimes surgery can help manage symptoms.

Study participation will last for about one year and three months (about 64 weeks). After completing the study, you and your study doctor may choose to either continue with the study treatment during a planned extension study or return to regular medical care.You may receive either the investigational medication or a placebo  every two weeks.   All participants will receive a subcutaneous injection (just under the skin) weekly for the first four weeks and then every two weeks for 16 weeks. You or a caregiver can administer some study doses at home. Study Treatment Period 2: After 16 weeks, all participants in the study will receive the investigational medication until the end of the study. Participants will again receive one injection weekly for four weeks and then every two weeks until the end of the study. You or a caregiver can administer some study doses at home. After completing the study, you and your study doctor may choose to continue with the study treatment during a planned extension study or return to regular medical care.

The study doctor or staff will explain all the details about the study, including risks and benefits, and answer your questions. If you decide to volunteer, you will be asked to sign an informed consent form indicating that you understand all the facts about taking part in the study.  . The study will include the following phases: Study Screening: You will attend a screening visit with the study doctor. At this visit, you will undergo tests and evaluations to determine if you are a good match for the study.


Qualified Participants Must:

• Be 18 years of age or older
• Have been diagnosed with HS a year or more before starting the study
• Have moderate to severe HS
• NO HEALTH INSURANCE REQUIRED


Qualified Participants May Receive:

Eligible participants will receive study medication,  study-related medical care  and  monertary up to $1150 for completing all study visits.


Available At:

FLORIDA ACADEMIC CENTERS RESEARCH AND EDUCATION, LLC
475 BILTMORE WAY, SUITE 207
Coral Gables, FL 33134
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If you or someone you care for is interested in participating and lives within 50 miles of the location shown, please complete the form below and click 'Submit'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.